Status:
COMPLETED
A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's Disease
Lead Sponsor:
Centocor, Inc.
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to examine the safety and efficacy of CNTO 1275 in participants with active Crohn's Disease.
Detailed Description
This is a multicenter, randomized study of IL-12p40 (CNTO 1275), hereafter referred to as ustekinumab, in 2 populations of participants with moderately to severely active Crohn's disease of at least 6...
Eligibility Criteria
Inclusion
- Have moderately to severly active Crohn's disease or fistulizing Crohn's disease for at least 6 weeks' duration with a Crohn's disease activity index (CDAI) score of \>=220 and \<=450
- In Population 1, participants must have had active disease despite treatment with 5-ASA compounds, antibiotics, corticosteroids, and/or immunomodulators, including anti-TNF agents. In Population 2, participants must have had active disease and have failed to respond to infliximab at the maximum approved dose and treatment regimen for Crohn's disease as defined in the US package insert.
Exclusion
- Have local manifestations of Crohn's disease such as strictures, abscesses, or other disease complications for which surgery might be indicated
- Had intra-abdominal surgery within 6 months prior to entering the study
- Have received treatment with parenteral nutrition (ie, introduction of nutrition into the body via a route other than the mouth) (total parenteral nutrition \[TPN\]) within 6 weeks of baseline
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00265122
Start Date
April 1 2004
End Date
October 1 2006
Last Update
February 13 2014
Active Locations (57)
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1
Scottsdale, Arizona, United States
2
Anaheim, California, United States
3
Sacramento, California, United States
4
San Francisco, California, United States